MAUDE Adverse Event Report: MICROVENTION, INC. FRED; FLOW DIVERTER

Model Number FRED5019

Device Problems Premature Activation (1484); Retraction Problem (1536)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/29/2021

Event Type  malfunction  

Manufacturer Narrative

A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was implanted in the patient and not returned to the manufacturer for analysis.Imaging from the procedure was provided, which shows the fred stent partially opened with the delivery catheter still near the proximal end of the fred stent.The fluoroscopic image does not clearly show the fred stent not opening, nor did it show its inability to resheath.The alleged product issue could not be confirmed.

Event Description

It was reported that a fred stent, used to treat an aneurysm, did not open to the physician's preference.Attempts to retract the stent were unsuccessful and the stent was left in place.There was no reported patient injury or intervention.

Event Description

It was reported that a fred stent, used to treat an aneurysm, did not open to the physician's preference.Attempts to retract the stent were unsuccessful and the stent was left in place.There was no reported patient injury or intervention.

Manufacturer Narrative

Correction: d6a (device was not implanted in the patient).Additional information: h10.Additional information received indicating that the stent stayed crimped after being unsheathed and was not opening correctly in the carotid siphon.The stent was deployed 75% when the physician attempted to re-sheath.Additional heparin was administered.The stent was successfully removed and replaced with another stent.The stent was still attached to the delivery wire at the time it was removed, which occurred during the same procedure.The instruction for use (ifu) instruct that if the fred® system positioning is not satisfactory, the implant may be recaptured and repositioned if it is not fully deployed.The implant may be recaptured until the point where the distal-most wire marker, collocated distal to the implant proximal markers, is aligned approximately 50% of length proximal to the microcatheter distal marker band.

• Brand Name: FRED
• Type of Device: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11904878
• MDR Text Key: 255703500
• Report Number: 2032493-2021-00194
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00811425020388
• UDI-Public: (01)00811425020388(11)200305(17)230228(10)20030554Z
• Combination Product (y/n): N
• PMA/PMN Number: P180027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: FRED5019
• Device Lot Number: 20030554Z
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1